Home-based Respiratory Training on Swallowing in Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-06-20

Brief Summary

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The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.

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Detailed Description

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This study aims to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Respiratory training added to orofacial exercises

Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.

Group Type EXPERIMENTAL

Respiratory training

Intervention Type DEVICE

Respiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength.

Orofacial exercises

Intervention Type OTHER

The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.

Orofacial exercises

Standard treatment including orofacial exercises.

Group Type ACTIVE_COMPARATOR

Orofacial exercises

Intervention Type OTHER

The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.

Interventions

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Respiratory training

Respiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength.

Intervention Type DEVICE

Orofacial exercises

The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of stroke
* 18 years of age or more

Exclusion Criteria

* Cognitive impairment or aphasia that prevents the understanding of instructions.
* Tracheostomy.
* Presence of cancer.
* Patients who present another disease of the central nervous system
* Absence of neuromotor competence to carry out the respiratory function tests.
* Central apnea.
* Hypoventilation-obesity syndrome.
* Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease).
* Patients with recent otorhinolaryngological, abdominal, or thoracic surgery.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No